Actively Recruiting
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Led by Stryker Craniomaxillofacial · Updated on 2025-10-20
110
Participants Needed
13
Research Sites
256 weeks
Total Duration
On this page
Sponsors
S
Stryker Craniomaxillofacial
Lead Sponsor
Q
Qmed Consulting A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.
CONDITIONS
Official Title
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is eligible for a PEEK customized implant as per routine clinical practice.
- Subject is 12 years of age or older (Europe only).
- Subject is 3.5 years of age or older (USA only).
- Adult subjects able to give consent.
- Subjects under the age of 18 will have a legal representative or parents (France - both parents must sign) to provide informed consent.
- Subjects who are unable to give consent themselves but have a legally authorized representative that may consent on their behalf.
You will not qualify if you...
- Subject has an active systemic or local infection.
- Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies.
- Compromised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant.
- Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care.
- Knowingly pregnant or nursing women.
- Concomitant participation in other clinical trials related to cranioplasty.
- Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of Louisville 501 E. Broadway, Suite 210
Louisville, Kentucky, United States, 40202
Enrolling by Invitation
2
Department of Neurological Surgery
New Brunswick, New Jersey, United States, 07101-1709
Enrolling by Invitation
3
Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
4
Lewis Katz School of Medicine at Temple University, 3401 North Broad Street
Philadelphia, Pennsylvania, United States, 19140
Enrolling by Invitation
5
Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA
Charleston, South Carolina, United States, 29425
Actively Recruiting
6
Universitätsklinik für Neurochirurgie Auenbruggerplatz 29
Graz, Austria, 8036
Actively Recruiting
7
Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9
Toulouse, Occitanie, France, TSA 40031 - 31059
Actively Recruiting
8
APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré
Paris, Paris France, France, 75010
Actively Recruiting
9
CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1
Nantes, Pays de la Loire Region, France, 44093
Enrolling by Invitation
10
St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263
Hamm, Hamm, Germany, 59073
Actively Recruiting
11
Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240
Dortmund, North Rhine-Westphalia, Germany, 44145
Actively Recruiting
12
Servicio de Neurocirugía Hospital Universitario La Paz.
Madrid, Madrid, Spain, 28046
Actively Recruiting
13
Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust
London, London, United Kingdom, SW7 2AZ
Actively Recruiting
Research Team
I
Ilka Meinert, Ph.D
CONTACT
S
Stephanie John, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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